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483
•Advanced Botanical Consulting & Testing, LLC•March 16, 2012

Advanced Botanical Consulting & Testing, LLC – FDA 483, Mar 16, 2012

Record Details

This FDA Form 483 was issued to Advanced Botanical Consulting & Testing Inc dba ABC Testing in Tustin, CA, a contract testing laboratory. The inspection revealed significant deficiencies in laboratory controls, method validation, record-keeping, computer system controls, equipment qualification, and quality control procedures. These issues indicate a lack of scientific soundness and control over analytical testing processes.

Company
Advanced Botanical Consulting & Testing, LLC
Inspection date
March 16, 2012
Product type
drugs
Office
Division of Pharmaceutical Quality Operations IV
People
  • Truong X. Nguyen (Investigator)
  • Uttaniti Limchumroon
  • Caryn Mcnab
  • Wendi Wang (President)
View Company Profile

ID · 9b5f0b3d-3e6e-4e72-b2c4-12acc4d802d0

Other documents for Advanced Botanical Consulting & Testing, LLC
  • 483 - 2021-03-15March 15, 2021
  • 483 - 2018-11-13November 13, 2018
  • EIR - 2012-03-16March 16, 2012

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